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U.S. Department of Health and Human Services

Class 2 Device Recall Zippie TS wheelchair

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  Class 2 Device Recall Zippie TS wheelchair see related information
Date Initiated by Firm January 13, 2012
Date Posted February 24, 2012
Recall Status1 Terminated 3 on February 27, 2012
Recall Number Z-1103-2012
Recall Event ID 61082
510(K)Number K973673  
Product Classification Wheelchair, mechanical - Product Code IOR
Product Sunrise Medical Zippie TS wheelchair

To empower physically challenged person by providing a means or mobility.
Code Information Model number: E1Z1A; Serial number: Z1SE-006474.
Recalling Firm/
Manufacturer		 Sunrise Medical (US) LLC
2842 N Business Park Ave
Fresno CA 93727-1328
For Additional Information Contact Laurie H. Roberts, RAC
559-294-2572
Manufacturer Reason
for Recall		 One Zippie TS Wheelchair was made per customer order was shipped with transit brackets for use a seat in a motor vehicle, however the chair was not configured with a back tested seat for motor vehicle use.
FDA Determined
Cause 2		 Employee error
Action Sunrise Medical contacted customer by telephone on January 17, 2012 to arrange for removal of transit brackets. The Sunrise Sales rep then visited the customers on January 18, 2012 and removed the bracket from the chair making it appropriate for intended use. If you need any additional information or have any questions, call 559-348-2572 or email: laurie.roberts@sunmed.com.
Quantity in Commerce 1 chair
Distribution Nationwide distribution: OK only.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IOR and Original Applicant = SUNRISE MEDICAL, INC.
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